Foresight Diagnostics Presents Independent Validation of its CLARITY Minimal Residual Disease (MRD) Assay in Multicenter Study of Frontline DLBCL at the 2025 ASCO Annual Meeting

• The data shows the prognostic value of Foresight CLARITY MRD detection at the end of frontline DLBCL in one of its largest prospective, real-world studies to date
• Data will be presented as an oral presentation on Friday, May 30, 2025, at 2:45 p.m. CT

BOULDER, Colo., May 22, 2025 /PRNewswire/ -- Foresight Diagnostics, Inc. ("Foresight"), a leading diagnostics company specializing in the development of ultra-sensitive minimal residual disease (MRD) detection, today announced the presentation of independent validation data demonstrating the prognostic performance of its Foresight CLARITY™ MRD assay in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). The results will be shared in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place from May 31 to June 3, 2025, in Chicago, Illinois.

The prospective, multi-center observational study, led by Amsterdam UMC in close collaboration with the Hemato-Oncology Foundation for Adults in the Netherlands (HOVON) and Netherlands Comprehensive Cancer Organization (IKNL), is the largest independent validation study of Foresight CLARITY to date, spanning more than 150 patients with frontline DLBCL treated uniformly with curative-intent therapy across 50 sites in the Netherlands and Belgium.

Key Findings:

• ctDNA-MRD was detected at end of treatment (EOT) in 24% of patients; 76% were MRD-negative.
• MRD-positive patients showed significantly lower progression-free survival (28% vs. 88%) and overall survival (50% vs. 97%) compared to MRD-negative patients.
• Among patients who were MRD-negative and achieved PET complete response at EOT, 2-year progression-free survival (PFS) and overall survival (OS) were 91% and 99%, respectively.
• All patients who failed to achieve complete response by PET and remained MRD-positive experienced relapse.
• ctDNA-MRD remained a powerful independent predictor of outcomes across multiple clinical subgroups, even after adjusting for standard prognostic factors.

"These results provide important prospective validation of Foresight CLARITY's clinical performance in frontline DLBCL across a large, real-world patient cohort," said David Kurtz, M.D., Chief Medical Officer of Foresight Diagnostics. "This study adds to a growing body of clinical evidence that we believe should strengthen the field's confidence in our assay's ability to accurately assess treatment response. We remain on track for a planned launch into the clinical market and look forward to integrating CLARITY into routine clinical practice."

Lead study authors Steven Wang, M.D. and Martine Chamuleau MD PhD, Amsterdam UMC, added: "Our findings confirm that ultra-sensitive ctDNA-MRD detection provides meaningful prognostic information beyond standard imaging and clinical factors. We believe this assay can support better risk stratification than imaging alone and inform post-treatment management decisions in DLBCL."

Oral presentation details:

• Title: Prospective validation of end of treatment ctDNA-MRD by PhasED-Seq in DLBCL patients from a national trial
  Presenter: Steven Wang, MD, PhD (Amsterdam UMC)
  Session: Oral Abstract Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
  Time:Friday, May 30 | 2:45 – 5:45 p.m. CT
  Location: Room S100a or live stream for virtual attendees
  Abstract number: 7000

In addition to the oral presentation, Foresight's technology will be highlighted in other presentations, including:

• "Sequencing-guided chemotherapy optimization using real-time evaluation in newly diagnosed DLBCL with circulating tumor DNA: SHORTEN-ctDNA" (NCT06693830) Presenter: Stephanie Meek, Ph.D. (Foresight) in collaboration with Columbia University
  Type: Poster #272a
  Session: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
  Date/Time: Sunday, June 1 | 9:00 a.m. – 12:00 p.m. CT | Poster Hall A
  
  
• "ALPHA3: A pivotal phase 2 study of first-line (1L) consolidation with cemacabtagene ansegedleucel (cema-cel) in patients (pts) with large B-cell lymphoma (LBCL) and minimal residual disease (MRD) after response to standard therapy"
  Sponsor: Allogene Therapeutics
  Presenter: Jason Westin, M.D., M.S., FACP (The University of Texas MD Anderson Cancer Center)
  Type: Poster #267a
  Session: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
  Date/Time: Sunday, June 1 | 9:00 a.m. – 12:00 p.m. CT | Poster Hall A

• "Safety and Efficacy of AZD0486, a CD19xCD3 T-cell Engager, in Relapsed or Refractory Diffuse Large B-cell Lymphoma" (NCT04594642)
  Sponsor: AstraZeneca
  Presenter: Tae Min Kim, M.D. (Seoul National University Hospital)
  Type: Poster #229
  Session: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
  Date/Time: Sunday, June 1 | 9:00 a.m. – 12:00 p.m. CT | Poster Hall A

• "Circulating tumor DNA assessment in patients with early-stage classical Hodgkin lymphoma treated with combination of brentuximab vedotin and nivolumab" (NCT03646123)
  Sponsor: Pfizer
  Presenter: Ryan Lynch, M.D. (Fred Hutchinson Cancer Center)
  Type: Poster #223
  Session: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
  Date/Time: Sunday, June 1 | 9:00 a.m. – 12:00 p.m. CT | Poster Hall A

About Foresight Diagnostics

Foresight Diagnostics is a privately held cancer diagnostics company and CLIA-registered laboratory. Its liquid biopsy platform, Foresight CLARITY™, is a novel assay that measures minimal residual disease (MRD) with reported detection limits in parts per million. The improved sensitivity of Foresight CLARITY™ has the potential to provide actionable information to physicians and biopharmaceutical companies to enable more personalized treatment approaches for patients with solid tumor and hematologic malignancies. For more information, please visit foresight-dx.com and follow us on X, LinkedIn, and Bluesky. Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use.

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SOURCE Foresight Diagnostics, Inc.